What is happening?
Regulation (EU) 2017/745 (EU MDR) of the European Parliament and of the Council of 5 April 2017 is a new Regulation governing medical devices. It amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repeals Council Directives 90/385/EEC and 93/42/EEC.
How will it affect Ascom?
As the manufacturer of a number of medical devices placed on the market in the EU, Ascom must remain in compliance with the EU MDR’s when they become effective. Ascom is currently reviewing, and where necessary, updating the Quality Management System (QMS), relevant QMS processes and product technical documentation, in order to ensure compliance with EU MDR, which enters into full effect 26 May 2020. From that date, the Ascom QMS and all Ascom medical devices -must comply with EU MDR provisions in order to be CE marked and placed on EU market. Existing class IIa/b/III MDD devices may be sold until the end of their current certifications, but may not undergo ‘significant’ changes. Existing class I MDD devices from stock may be sold until 27 May 2025, but no changes to the devices are allowed.
EU MDR will impose stricter vigilance and market surveillance requirements on medical device companies. Once available on the market, manufacturers “will be obliged to collect data about [the devices’] performance and EU countries will coordinate more closely in the field of market surveillance”.*
EU MDR in brief:
• The creation of a new European database (EUDAMED) for medical devices
• The introduction of a Universal Device Identifier (UDI) for all medical device products and software. UDIs must be uploaded to EUDAMED, and must provide upstream and downstream traceability.
• Stricter rules governing clinical claims. Ascom must support all clinical claims with clinical data that has been collected and presented in a systematic, scientifically valid way.
Learn more about EU MDR and its implications for Ascom
• The full text (in English) of Regulation (EU) 2017/745 is available here.
A fact sheet (pdf) issued by the European Commission is available here.